la roche posay laboratoire dermatologique cicaplast balm b5 uv broad spectrum spf 50 sunscreen skin protectant

Generic: dimethicone, homosalate, octisalate, octocrylene and zinc oxide

Labeler: loreal usa products inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name la roche posay laboratoire dermatologique cicaplast balm b5 uv broad spectrum spf 50 sunscreen skin protectant
Generic Name dimethicone, homosalate, octisalate, octocrylene and zinc oxide
Labeler loreal usa products inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

dimethicone 10 mg/mL, homosalate 80 mg/mL, octisalate 50 mg/mL, octocrylene 50 mg/mL, zinc oxide 70 mg/mL

Manufacturer
LOreal USA Products Inc

Identifiers & Regulatory

Product NDC 49967-199
Product ID 49967-199_b2f0c42f-aea9-413f-8d08-da5bcec7dfc7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49967199
Hyphenated Format 49967-199

Supplemental Identifiers

UPC
3606000621992
UNII
92RU3N3Y1O V06SV4M95S 4X49Y0596W 5A68WGF6WM SOI2LOH54Z
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name la roche posay laboratoire dermatologique cicaplast balm b5 uv broad spectrum spf 50 sunscreen skin protectant (source: ndc)
Generic Name dimethicone, homosalate, octisalate, octocrylene and zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 80 mg/mL
  • 50 mg/mL
  • 70 mg/mL
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (49967-199-01) / 40 mL in 1 TUBE
  • 20 TUBE in 1 PACKAGE (49967-199-02) / 5 mL in 1 TUBE
source: ndc

Packages (2)

49967-199-01 1 TUBE in 1 CARTON (49967-199-01) / 40 mL in 1 TUBE 49967-199-02 20 TUBE in 1 PACKAGE (49967-199-02) / 5 mL in 1 TUBE

Ingredients (5)

dimethicone (10 mg/mL) homosalate (80 mg/mL) octisalate (50 mg/mL) octocrylene (50 mg/mL) zinc oxide (70 mg/mL)

Linked Drug Pages (1)

LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "b2f0c42f-aea9-413f-8d08-da5bcec7dfc7", "openfda": {"nui": ["N0000010282"], "upc": ["3606000621992"], "unii": ["92RU3N3Y1O", "V06SV4M95S", "4X49Y0596W", "5A68WGF6WM", "SOI2LOH54Z"], "spl_set_id": ["e8539a43-db85-451c-bce8-2c488f3dc40d"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["LOreal USA Products Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (49967-199-01)  / 40 mL in 1 TUBE", "package_ndc": "49967-199-01", "marketing_start_date": "20240601"}, {"sample": false, "description": "20 TUBE in 1 PACKAGE (49967-199-02)  / 5 mL in 1 TUBE", "package_ndc": "49967-199-02", "marketing_start_date": "20240601"}], "brand_name": "LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant", "product_id": "49967-199_b2f0c42f-aea9-413f-8d08-da5bcec7dfc7", "dosage_form": "CREAM", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "49967-199", "generic_name": "Dimethicone, Homosalate, Octisalate, Octocrylene and Zinc oxide", "labeler_name": "LOreal USA Products Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant", "active_ingredients": [{"name": "DIMETHICONE", "strength": "10 mg/mL"}, {"name": "HOMOSALATE", "strength": "80 mg/mL"}, {"name": "OCTISALATE", "strength": "50 mg/mL"}, {"name": "OCTOCRYLENE", "strength": "50 mg/mL"}, {"name": "ZINC OXIDE", "strength": "70 mg/mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}